ESDR I JSID I SID Abstracts
1291 ALLERG~LC POTENTL4L. OF OATMEAL
EXTRA(XS AND PROTBlNS OF OAT EXTRACTS USING A MAXlMUATlON TEST.KVY F. b&rot?. B. FabreiJ &&,,&.LFiinc-Fabrbre Rcs+x,tcb InsIitute, Toulouse, ~EvicCeba, Blanquefort, 1DermoCosmetic Research Center, Catanet-Tolosan, France oatmeal eaacts derived from Avena satin am tmdionnally used in the treatment of k&ted skin for their moishuizing and anti-intlamm&ry properties, but are &ought to be allergenic. Recently, we developed a new e.x!mct Avena Rixalba which was shown to have bettm anti-i,,Bammatory pmpaties. Tix puqmse of this study was to evaluate and compare the allereenic cotential of Avma sativa and Avena Rhealba using a marimizatton feet as described by h&adli and Maibach 96 volunteers, whose 19 (20%) had history of atopic or allergic dermatitis, were included in tix study. The test was performed on the back of the vcdunteea as follows induction phase witi occlusive 48hour patches for 21 days with Avena sativa 3%, Avena Rhealba 3%, their msoective omteio fmdions 0 5%. and their vehicle (uetmlatum ointment) This was followed bya Z-week rat p&cd, and a &lenge with a 48 l&-patch at the ind&n site as well as a new skin site. Reading of the rwctions were made 30 minuts, 24 hours and 48 hours after patch removal, according to the ICDRG ctiteda. 3 diffennt subjeds developed a non specific reaction (eryfhema) with one of the following e&acts Awna sativa (vol. ref. 6), profeis fmctions of Avena sativa (vol. ref. 56) and protein fractions of Avena Rhexdba(vol.ref 70). When these 3 subjects were rcchallenged, 1 month lam, with the suspected materials, no skin mation was observed. Accordingly, these results arc indicatwe of a none allergenic potential of oatmeal exhacts
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1292
1295
TRETINOIN AQUEOUS GEL: A NOVEL EFFICACIOUS FORMULATION WlTH LOW DERMAL IRRITATION. G.J. Gendimenico. J. A. Mezick, Johnson B Johnson Consumer Products Worldwide, Skillman, NJ, USA Tretinoin is an effective topical derrnatotherapeuhc retinoid however, its use can be limited due to an irritant reaction consisting of erythema and scaling. Thus, efficacious but less irritating tretinoin formulations would be a significant advance in patient usage and acceptability. A non-alcoholic aqueous gel tretinoin formulation (TAQG) has been developed with a markedly improved therapeutic index (T.I. = ratio of irritation to activity) compared to tretinoin alcohol gels. Predtnically, the rhino mouse utriculus assay, and rabbit derrnal irritation were used to determine therapeutic indices of tretinoin formulations. In the rhino mouse, TAQG was equipotent to alcoholic tretinoin formulations, but signiticantly less irritating to rabbit skin compared to tretinoin alcohol gel. This resulted in a T.I. of 17 for TAQG versus 1 for tretinoin alcohol gel. Tretinoin from TAQG peneated into, but not across human skin in vitro. When tested for cumulative irritation in human skin, 0.05% TAQG caused 2.5 times less irritation than 0.01% tretinoin alcohol gel. In a 4day human bioassay, 0.025% and 0.15% TAQG caused increased epidermal thickness and CRABP-II mRNA similar to 0.025% tretinoin in alcohol/propylene glycol. These findings indicate that TAQG should be efficacious and better tolerated in clinical use compared to other tretinoin alcoholic formulations.
TESTING IN REPETITIVE EPICUTANEOUS SKIN COMPATIBILITY INVESTIGATIONS: A POWERFUL METHOD FOR DISCRIMINATION OF MINOR ACUTE IRRITANCY POTENTIAL E. J. Fnnan; Paul Gerson Unna-Skin Research Center, AG. Hamburg, Germany The evaluation of the local skin tolerance of cosmetic formulations has to take two circumstances into account: Firstly, the demands of the consumer for skin compatibility and mildness has increased considerably in recent years. Secondly, there has been a rise of consumers’ skin sensitivity. In this investigation we focussed on possible acute irritency reactions induced by cosmetics and on options to test formulas under conditions to maximise the response. In general, the single application occlusive patch test IS appropriate to identify strong or moderate irritant formulations or raw materials. However, for discrimination of low or very low acute irritancy characteristics this test appears to be less suitable. To overcome this problem, we propose a repetitive application patch test characterized by a cumulative application of the product on four consecutive days. To avoid initant reactions induced by removal of patches, we firstly apply carrier plasters with a centered hole on the backs of human volunteers. We apply skin care products for 21 hrs on skin site up to four times. Our results clearly show that this new epicutaneous patch test method gives a high degree of discnmination. In particular, when a cosmetic has to be optimized for ~nsumers with sensitive skin, this experimental tool is of high value since variants can be compared among each other and with benchmark products respectively. In various repetitive patch tests we succeeded in identifying the mildest candidates from a series of new formulations which all exhibit a high skin compatibilly as indicated rn the single appltcation patch test. In conclusion. epicutaneous repetitive in viva testing is an effective way to optimize cosmetic formulas in cosmetic development and research.
Beiersdorf
1296 TOLERANCE PROFILE OF THE RETINALDEHYDE, AND RETINOIC Pi lPiaw,-Fabre Research
3 TOPICAL RETINOIDS RETINOL, ACID MP. Viennd. J. Fluhrz. C. Law.@, Institute, Toulouse, France ?Hatilinik
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Karlsluh$ KarlsNhe, Gemlany. The aim of our study wan to compare the local tolerance of 3 natural ret&ids indicated in photoaging, i.e. retinal, retinaldehyde and retinoic acid, in maximized condition For this purpose, retinal 0.07%, retinaldehyde 0.05% and retinoic acid 0.05% were applied under occlusion on the forearms of 6 human volunteers, for 14 days. One hour after the last patch removal, measurements of Trans Epidermal Water Loss (ll?WL) using an evaporimete? (Serwtned) and blood flow Perfusion Unit (PU) with a laser doppler @rimed) were perfamed. At baseline, TEWL and PIJ values were comparable be-n tieatment groups. At the end of treatment, the respective TBWL change from baseline (mew SEM) with retinal, retina)dehyde and retinoic acid were the followings + 9.7 f 3.7 (NS), + 15.6 -t 4.7 (NS), + 17.4 + 5 (NS). Similary, mean changes of PU values were + 8.3 i 4.7 with ret&l (NS), + 12.2 +_ 5.2 with retinaldehyde (NS), and + 43.3 + 10.4 with retinoic acid @=O.W, Wilcoxon test) Differences between trestrtterd groups with PU p-&t at the end of treatment were statistically significant, in favor of retinol and retinaldehyde QKO.05, Bonfernmi test). In conclusion, retinaldehyde than retinoic acid.
and retinol seems to display
a better tolerance
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